Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care (PTN_POPS)

Verified March 2017 by Daniel Benjamin, Duke University Medical Center

Sponsor:

Daniel Benjamin

ClinicalTrials.gov Identifier:

NCT01431326

First Posted: September 9, 2011

Last Update Posted: March 22, 2017

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Collaborators:

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Understudied drugs will be administered to children per standard of care as prescribed by their treating caregiver and only biological sample collection during the time of drug administration will be involved. A total of approximately 3000 children aged <21 years who are receiving these drugs for standard of care will be enrolled and will be followed for up a maximum of 90 days. The goal of this study is to characterize the pharmacokinetics of understudied drugs for which specific dosing recommendations and safety data are lacking. The prescribing of drugs to children will not be part of this protocol. Taking advantage of procedures done as part of routine medical care (i.e. blood draws) this study will serve as a tool to better understand drug exposure in children receiving these drugs per standard of care. The data collected through this initiative will also provide valuable pharmacokinetic and dosing information of drugs in different pediatric age groups as well as special pediatric populations (i.e. obese).

Further study details as provided by Daniel Benjamin, Duke University Medical Center:

Primary Outcome Measures:

Composite of pharmacokinetic outcomes for understudied drugs in children [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ]

As appropriate for each study drug, the following additional PK parameters will be estimated:

maximum concentration (Cmax)

time to achieve maximum concentration (Tmax)

absorption rate constant (ka)

elimination rate constant (kel)

half-life (t1/2)

area under the curve (AUC)

Penetration into body fluids will be determined by comparing exposure (i.e. AUC, Cmax) ratios between the body fluid and plasma or comparison of concentrations in paired samples.

Secondary Outcome Measures:

Composite pharmacodynamic outcomes of understudied drugs in children [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ]

When applicable, Monte Carlo simulations will be performed to evaluate therapeutic target attainment rates (pharmacodynamics) in the population of interest. The final PK model and parameters estimated in the population PK analysis will be used to perform these simulations.

Biomarkers associated with understudied drugs in children [ Time Frame: Data will be collected throughout the hospital or outpatient stay up to 90 days ]

The dosing, sampling, and demographic information recorded on the eCRF will be merged with the bioanalytical information to create a biomarker dataset for each study drug. Biomarkers will be identified using metabolomics/proteomics and pharmacogenomics methodologies. Samples for biomarker analysis will be stored for future use in a PTN designated biorepository. Associations between biomarkers and drug exposure will be explored by visual inspection (i.e. scatter plots) and statistical comparisons as needed.

Drug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:

Other Names:

aripiprazole

ceftazidime

cidofovir

ciprofloxacin

dexamethasone

diazepam

levetiracetam

meropenem

methylprednisolone

midazolam

nicardipine

olanzapine

oseltamivir

oxycarbazepine

phosphenytoin

quetiapine

risperidone

timolol

topiramate

valproic acid

tobramycin

alfentanil

clozapine

fosphenytoin

haloperidol

heparin (low molecular weight)

hydromorphone

lurasidone

molindone

morphine

pentobarbital

propofol

warfarin (oral)

ziprasidone

Detailed Description:

The purpose of this study is to characterize the PK ( Pharmacokinetics) of understudied drugs administered to children per standard of care as prescribed by their treating caregiver. This will be accomplished by the collection of biological samples during the time of drug administration per standard of care as prescribed by the caregiver. The prescribing of drugs to children will not be part of this protocol.

Aim #1: Evaluate the PK of understudied drugs currently being administered to children.

Hypothesis #1: The PK of understudied drugs in children will differ from adults and within children according to pediatric age groups or special population.

Aim #2: Explore the pharmacodynamics (PD) of understudied drugs currently being administered to children.

Hypothesis #2: The PD of targeted drugs in children will differ from adults.

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Ages Eligible for Study:

up to 21 Years (Child, Adult)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Children (<21 years of age) receiving drugs per standard of care as prescribed by treating caregiver

Criteria

Inclusion Criteria:

1) Children (< 21 years of age) who are receiving understudied drugs of interest per standard of care as prescribed by their treating caregiver

Exclusion Criteria:

1) Failure to obtain consent/assent (as indicated)

2) Known pregnancy as determined via interview or testing if available.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01431326